In short
Clinical trials are studying VRDN-003 in people with thyroid eye disease (TED). These studies look at safety, tolerability, and whether VRDN-003 improves signs and symptoms such as eye bulging and disease activity. The trials include people with TED of any duration, chronic TED, and active TED.
Key points
- Clinical trials are studying VRDN-003 in thyroid eye disease, including people with TED of any duration, chronic TED, and active TED. All listed studies are Phase 3 and are authorised. The trials focus on safety, tolerability, and whether VRDN-003 improves eye bulging and disease activity. Some studies compare VRDN-003 with placebo. Main results are measured at Week 24.
Clinical trial overview
The available studies are testing VRDN-003 in people with thyroid eye disease (TED), a condition that affects the eyes. All three trials are Phase 3 and have been authorised.
These studies are looking mainly at safety, tolerability, and whether VRDN-003 improves signs and symptoms of TED. Two of the studies compare VRDN-003 with placebo, which is a treatment with no active drug ingredients.
The three Phase 3 studies
The first study, NCT06812325, is a safety and tolerability study in participants with TED of any duration. It includes 322 participants and checks safety events through Week 24.
The second study, 2024-514973-23-00, looks at efficacy, safety, and tolerability in people with chronic TED. It includes 204 participants and measures the Overall Responder Rate at Week 24.
The third study, 2024-514972-42-00, is for people with active TED. It includes 142 participants and also measures the Overall Responder Rate at Week 24.
In these studies, VRDN-003 is given as a series of subcutaneous injections, which means injections into the fat layer under the skin. The studies test dosing every 4 weeks or every 8 weeks.
Who the trials include
These trials are for people with thyroid eye disease. One study includes people with TED of any duration, one focuses on chronic TED, and one focuses on active TED.
This means the studies are looking at different stages of the same disease, so researchers can see how VRDN-003 performs in different patient groups.
What the trials measure
The first study measures the rate of treatment-emergent adverse events, which are safety events that happen after treatment starts, through Week 24.
The second and third studies measure the Overall Responder Rate at Week 24. In the chronic TED study, an overall responder is someone with at least a 2 mm reduction in eye bulging and no worsening in CAS at Week 24 compared with before the first dose. In the active TED study, an overall responder is someone with at least a 2 mm reduction in eye bulging and a CAS reduction of at least 2 points at Week 24 compared with before the first dose.
These endpoints help researchers understand both effectiveness and safety in a clear way.
Simple explanation of key terms
Safety means how often unwanted health problems happen during the study.
Tolerability means how well people can take the treatment, or how acceptable it is to the body.
Clinical Activity Score, or CAS, is a way to estimate disease severity and symptoms.
Placebo means a treatment with no active drug ingredients, used for comparison.
Week 24 is the point 24 weeks after treatment starts, when the main study results are checked.